Alex White (Dublin South, Labour) | Oireachtas source

The question of the kind the Deputy mentions would not arise. That is a newly patented drug. That is not what we are talking about here. We are talking about generic substitution. I can understand people's concerns and this is new to our system. We have never had proper legislative provision for generic substitution. It is not a willy-nilly charter for cheap drugs. It is unfortunate that this impression has been given.

Section 5 is very rigorous. The Irish Medicines Board is required to apply considerable tests. I know we are not discussing section 5 but so many references are being made to this issue that I feel it necessary to make it absolutely clear to the committee that this is not some kind of charter for cheap drugs. We are imposing a rigorous requirement on the Irish Medicines Board only to allow generic drugs in the circumstances contemplated in section 5.

The issue that is germane to section 4 is Deputy Kelleher's original question about how quickly the board will move. He and others then moved on to other issues to do with timelines which are also relevant to section 5. In response to the question about the board, the legislation is being introduced to ensure value for money in the supply of medicines. That is an overall requirement. Therefore, the medicines that will be reviewed first are those that cost the most for the patient or the Exchequer. The Department of Health has asked the Irish Medicines Board to prioritise the classes of medicine that result in the greatest cost. There are 20 currently identified, including statins, proton pump inhibitors, angiotensin-converting enzyme or ACE inhibitors, and angiotensin II receptor blockers. I have a table that I can give to the committee. There are 6,000 different items, so this will have to be phased in. It will not be possible to do it immediately or quickly across the board. The Irish Medicines Board is expert in this area. The Department of Health has held conversations with it about its general work programme. It will deal with the areas that I have mentioned first and it will take time for the matter to be addressed.